[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76081-76082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26182]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1736]
Potential Approach for Ranking of Antimicrobial Drugs According
to Their Importance in Human Medicine: A Risk Management Tool for
Antimicrobial New Animal Drugs; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting and request for comments; extension of
comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice announcing a public meeting
and requesting comments that appeared in the Federal Register of
October 13, 2020. In that notice, FDA announced a public meeting, held
on November 16, 2020, and requested public input on a potential revised
approach for considering the human medical importance of antimicrobial
new animal drugs when assessing and managing the antimicrobial
resistance risks associated with the use of antimicrobial drugs in
animals. Specifically, the Agency requested comments on the potential
revised process for ranking antimicrobials according to their relative
importance in human medicine, on the potential criteria for their
ranking, and on the resulting ranked list of antimicrobial drugs. FDA
is taking this action in response to several requests for extension to
allow interested persons additional time to submit comments.
DATES: FDA is extending the comment period announced in the notice of
public meeting and request for comments published October 13, 2020 (85
FR 64481). Submit either electronic or written comments by March 16,
2021, to ensure that the Agency considers your comments regarding this
public meeting and request for comments.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2020-N-1736 for ``Potential Approach for Ranking of Antimicrobial
Drugs According to Their Importance in Human Medicine: A Risk
Management Tool for Antimicrobial New Animal Drugs.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts
[[Page 76082]]
and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Kelly Covington, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 240-402-5661, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of October 13, 2020,
FDA published a notice announcing a public meeting and requesting
comments on a concept paper entitled ``Potential Approach for Ranking
of Antimicrobial Drugs According to Their Importance in Human Medicine:
A Risk Management Tool for Antimicrobial New Animal Drugs'' with a 94-
day comment period.
Interested persons were originally given until January 15, 2021, to
comment on the public meeting and request for comments. The Agency
received several requests to allow interested persons additional time
to comment. The requests conveyed concern that the initial 94-day
comment period did not allow sufficient time to develop a comprehensive
response. FDA believes that an extension of 60 days allows adequate
time for interested persons to submit comments.
Dated: November 20, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26182 Filed 11-25-20; 8:45 am]
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